Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.

December 12, 2024 updated by: Riphah International University
Pain is an "unpleasant sensory and emotional experience (associated with actual or potential tissue damage". Chronic pain is a sensation of hyperalgia to muscles, ligaments and skin on both active and passive movements. Chronic pain has a tendency to prevent people from working and exercising

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neck pain is a very common clinical condition which equals the economic, social cost and level of disability to that of low back pain.Mechanical neck pain that occurs without an identifiable underlying disease and anatomical abnormality is termed as "non-specific" neck pain (NS-NP).Mechanical neck pain commonly arises insidiously and is generally multifactorial in origin.Two most common complains associated with chronic specific and non-specific neck pain are Kinesiophobia (fear of movement) and Postural asymmetry (forward head posture). Medical, surgical and physical therapy treatments are recommended for addressing chronic non-specific neck pain. Within the scope of physical therapy conventional management consist of many different techniques such as therapeutic exercises, electrotherapy, Pilates, yoga and manual therapy. Manual therapy is among the most common used method for treating musculoskeletal conditions including chronic neck pain. Manual therapy consists of stretching techniques, joint mobilization/manipulation, isometric/dynamic strengthening exercises and fascial manipulation or release. Global Postural Re-education (GPR) is an alternative therapeutic strategy based on the concept that postural muscles are organized in the form of 'muscle chains' located on the anterior and posterior aspect of the spine. It involves the global stretching of the anti-gravitational muscles and the kinetic muscle chains.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 46000
        • Islamabad Physiotherapy and Rehabilitation Centre (IPRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic non-specific neck pain ≥ 3 months.
  • No prior medication and Physical Therapy interventions from last 3 months.
  • Pain: moderate level (6 on NPRS).

Exclusion Criteria:

  • History of any trauma .
  • History of any psychological condition.
  • Specific causes of Neck Pain (e.g., systemic, rheumatic, neuromuscular diseases).
  • Presence of central and peripheral neurological sign.
  • Spinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Global Positional Re-education
Other: Global Positional Re-education
A series of gentle active movements and postures aimed at realigning joints and stretching shortened muscles. GPR includes 8 therapeutic postures in lying, sitting and standing.
Active Comparator: Conventional Physical Therapy Program
Conventional therapy will consist of a combination of manual techniques
Other: Conventional Physical Therapy Program
Axial traction will be given for 5 minutes, followed by mobilization of the muscle fascia along with static stretching of the scalene, levator scapulae, upper trapezius, sternocleidomastoid and pectoralis minor muscles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: six weeks
The NPRS is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six weeks
Neck Disability Index
Time Frame: six weeks
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six weeks
Goniometer for Cervical Range of Motion
Time Frame: six weeks
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six weeks
Tampa Scale of Kinesiophobia
Time Frame: six weeks
Tampa Scale of Kinesiophobia (TSK). TSK is a 17-items questionnaire based on the evaluation of fear of movement, fear of physical activity and fear of re-injury in patients suffering from chronic musculoskeletal pain. It is the most widely used fear avoidance behavior questionnaire with good level of reliability and validity as documented in different literatures. TSK is composed of 17 items with score ranging from 1to 4 for each item, ultimately having a total score ranging from 17-68.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forward Head Posture:
Time Frame: six weeks
Ruler method. This method involves measuring the distance from the wall to the tragus of the ear (Tragus to wall test) and from wall to the posterior aspect of acromion of shoulder by a ruler in standing position. The normal distance of Tragus to wall (TTW) in males is 10.55 cm and in females is 10.00 cm, whereas the normal distance of shoulder from wall in relaxed standing position should be less than 5 cm.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six weeks
Global Perceived Effect Questionnaire:
Time Frame: six week
Perceived effect of the intervention will be assessed by using the Global Perceived Effect Questionnaire (GPE), a 5-point Likert-type scale evaluating the subjective self-reported improvement or deterioration after the intervention. GPE is widely used in the physical therapy literature. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
six week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria khalid, MSOMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/00941 Faisal Saeed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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